Over-the-counter drug · ANDA
Ibuprofen 200mg NDC 53185-381
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Athlete's Needs, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53185-381-01 | 5318503810153185038101 | 100 TABLET, COATED in 1 BOTTLE (53185-381-01)Marketed from Oct 7, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ibuprofen 200mg
- Generic name (nonproprietary)
- ibuprofen 200mg
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Athlete's Needs, Inc.NDC labeler code 53185
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202312
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53185-381_9925c48b-f4aa-4393-b877-84307eb271e1SPL ID 9925c48b-f4aa-4393-b877-84307eb271e1SPL set ID 2db10105-6fd3-420d-8889-7cfd6f396e5fRxCUI 310965UNII WK2XYI10QMUPC 0092617275414
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N453185038101followed by a unit qualifier and the quantityPackage 53185-0381-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53185-381
- What is NDC 53185-381?
- 53185-381 is the product NDC for Ibuprofen 200mg, Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Athlete's Needs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen 200mg.
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Athlete's Needs, Inc., NDC labeler code 53185. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen 200mg?
- 4 other product NDCs are listed under this name. See all Ibuprofen 200mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen 200mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-467 | 69168-0467-0169168-0467-0369168-0467-05+2 more |
| Ibuprofen 200mgibuprofen | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-381 | 69168-0381-0169168-0381-0369168-0381-05+3 more |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-382 | 69168-0382-30 |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-390 | 69168-0390-30 |
Other NDCs under ANDA 202312
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Assured Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceuticals LLC | 68210-4139 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Walgreens | 0363-9593 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | BETTER LIVING BRANDS LLC. | 21130-358 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | BETTER LIVING BRANDS LLC. | 21130-359 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | TOPCO ASSOCIATES LLC | 36800-286 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-662 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-116 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-312 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-865 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Demoulas Super Markets, Inc | 53942-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-811 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-320 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-321 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-570 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-571 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-301 |
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